ERNIE-Evaluating Response to an individualized Neuropsychological IntervEntion for children with brain tumors: study protocol for a randomized controlled trial.
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BACKGROUND: Although survival rates for children with brain tumors have improved, many face neuropsychological challenges that can affect quality of life and daily functioning. Existing interventions are typically standardized, with limited evidence supporting their effectiveness, and often do not explicitly target individual or systemic needs. The ERNIE study aims to address these gaps by evaluating the efficacy and process of an individualized, family-centered neuropsychological intervention. The primary research question is to evaluate the efficacy of an individualized versus standardized neuropsychological intervention immediately after treatment completion. METHODS: The ERNIE study is a single-center, prospective, superiority randomized controlled trial at the Princess Máxima Center for Pediatric Oncology in the Netherlands. Eligible participants are children aged 8 to 17 years with cognitive problems following completion of brain tumor treatment. Enrollment began in November 2024 and will continue for two years, with the study team aiming to recruit 144 participants. Participants and parents are randomly assigned (1:1) to an individualized or a standardized neuropsychological intervention, each comprising six sessions of psychoeducation and strategy training over three months. Randomization is stratified by age (8-12/13-17 years) and cognitive impairment (mild/severe). Outcome assessors and families are blinded to allocation, whereas therapists cannot be blinded due to the nature of the intervention. The primary outcome is Goal Attainment Scaling (GAS), assessed through a patient and parent interview post-intervention. Other outcomes are goal satisfaction, cognitive and psychosocial outcomes, and measures of the intervention process, including recruitment feasibility, intervention completion, data collection, and implementation factors such as facilitators and barriers. A six-month internal pilot will provide an early assessment to inform study procedures. Assessments occur pre-intervention, post-intervention (~ 3 months), and follow-up (~ 12 months). Safety monitoring aligns with low-risk studies. DISCUSSION: The ERNIE study compares an individualized neuropsychological approach with a standardized approach. By integrating outcome assessment with process evaluation, the study seeks to generate evidence on both efficacy and implementation feasibility. Findings may help shape future clinical practices by investigating the impact of individualized neuropsychological interventions to improve daily functioning in this vulnerable group of children. TRIAL REGISTRATION: ISRCTN trial registry ISRCTN30985676, registered on 04 October 2024. https://www.isrctn.com/ISRCTN30985676 .